The current medical device landscape has turned challenging for manufacturers in terms of ensuring quality and audit compliance due to ever-evolving regulations which may lead to extended time for approvals and market access.

Artwork services for the current Consumer Healthcare/Food Supplements landscapes are divided as per the markets. For Compliance based markets, artworks are created by Freyr team and submitted to the client for finalizing the artwork/ label.

Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance.

Evaluation and Submission of Response to Screening Deficiency

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The client, a drug development company based in the US, approached Freyr for the complete evaluation and submission of response to screening deficiency. Freyr team evaluated the screening deficiency and strategy preparation to respond. After a thorough discussion with the client the team prepared response and sections.

Read the case to know different challenges faced by the Freyr team while evaluating and submitting the response.